(280 days)
The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Breeze," a motorized three-wheeled vehicle (scooter) manufactured by Afikim Electric Vehicles. This letter grants clearance for the device based on its substantial equivalence to a legally marketed predicate device, but it does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.
The document states:
- Device Name: Breeze
- Regulation Number: 21 CFR 890.3800
- Regulation Name: Motorized three-wheeled vehicle
- Regulatory Class: II
- Product Code: INI
- Indications for Use: "The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suitable for the use of elderly persons and physically disabled persons."
Since this document is simply an FDA clearance letter, it does not include the detailed technical study information you are requesting. Such information would typically be found in the 510(k) submission itself, which is a much more extensive document. Therefore, I cannot provide the requested details about acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications based on the provided text.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).